Investigation of the 24 Hour Forced Expiratory Flow in 1 Second (FEV1) Profile of a Single Dose of QMF Twisthaler (Indacaterol Maleate/Mometasone Furoate) - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00557440

Purpose

This study is designed to provide data about the 24 hours FEV1 profile, safety and tolerability of QMF Twisthaler compared to placebo and using fluticasone propionate/salmeterol as an active control.

Condition	Intervention	Phase
Asthma	Drug: Fluticasone propionate/salmeterol Drug: Indacaterol maleate / mometasone furoate Drug: placebo	Phase II

MedlinePlus related topics: Asthma

Drug Information available for: Fluticasone propionate Mometasone furoate Salmeterol Fluticasone Salmeterol xinafoate Indacaterol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	A Multi-Center, Randomized, Double-Blind, Double Dummy, Placebo and Active Controlled Crossover Study, to Investigate the 24 Hour FEV1 Profile of a Single Dose of QMF Twisthaler in Adult Patients With Persistent Asthma

Further study details as provided by Novartis:

Primary Outcome Measures:

Mean change from (period) baseline FEV1 to 24 hour post-dose trough FEV1, compared with placebo. [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

FEV1 standardized area under the curve (AUC) between baseline (pre-dose) and 4 h post-dosing [ Time Frame: 1 day ] [ Designated as safety issue: No ]
FEV1 standardized area under the curve (AUC) between baseline (pre-dose) and 23 h 45 min post-dosing [ Time Frame: 1 day ] [ Designated as safety issue: No ]
FEV1 standardized area under the curve (AUC) between 11 h 10 min and 23 h 45 min post-dosing [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Enrollment:	37
Study Start Date:	November 2007
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Indacaterol maleate / mometasone furoate QMF Twisthaler 500/400 μg o.d.
2: Placebo Comparator	Drug: placebo Placebo b.i.d.
3: Active Comparator	Drug: Fluticasone propionate/salmeterol Fluticasone/salmeterol 250/50 μg b.i.d.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and female adult patients aged 18-75 years (inclusive), who have signed an Informed Consent Form prior to initiation of any study-related procedure,
Patients with persistent asthma, diagnosed according to GINA guidelines (National Institute of Health, National Heart, Lung and Blood Institute, 2006) and who additionally meet the following criteria:
- Patients receiving daily treatment with inhaled corticosteroid up to the maximum dose per day indicated in the product label, in a stable regimen for the month prior to Visit 1.
- Patients with an FEV1 at Visit 1 ≥50% of predicted normal.
- Patients who demonstrate an increase of ≥12% and ≥200 mL in FEV1 over their pre-bronchodilator.

Exclusion Criteria:

Pregnant women, nursing mothers, or females of childbearing potential, regardless of whether or not sexually active, if they are not using a reliable form of contraception.
Patients who have used tobacco products within the 6 months period prior to Visit 1, or who have a smoking history of greater than 10 pack years.
Patients diagnosed with Chronic Obstructive Pulmonary disease (COPD) as defined by the GOLD guidelines (Global Initiative for Chronic Obstructive Lung Disease 2006).
Patients with seasonal allergy whose asthma is likely to deteriorate during the study period.
Patients who have had an acute asthma attack/exacerbation requiring hospitalization in the 6 months prior to Visit 1.
Patients who have had an acute asthma attack / exacerbation requiring an emergency room visit within 6 weeks prior to Visit 1 or at any time between Visit 1 and Visit 2.
Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1 or at any time between Visit 1 and Visit 2.
Patients with a history of long QT syndrome or whose QTc interval (Bazett's) measured at Visit 1 or Visit 2 is prolonged: > 450 ms (males) or > 470 ms (females).
Other clinically significant conditions which may interfere with the study conduct or patient safety as specified in the protocol.

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00557440

Locations

Belgium
Novartis Investigator site
Ghent, Belgium
Novartis Investigator Site
Aalst, Belgium
Germany
Novartis Investigator Site
Landsberg, Germany
Novartis Investigator Site
Rostock, Germany
Novartis Investigator Site
Hannover, Germany
Novartis Investigator Site
berlin, Germany

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis Pharma

More Information

No publications provided

Responsible Party:	novartis ( external affairs )
Study ID Numbers:	CQMF149A2202
Study First Received:	November 12, 2007
Last Updated:	April 6, 2009
ClinicalTrials.gov Identifier:	NCT00557440 History of Changes
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products; Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:

Asthma
QMF
Indacaterol
Mometasone

Study placed in the following topic categories:

Anti-Inflammatory Agents
Neurotransmitter Agents
Salmeterol
Adrenergic beta-Agonists
Adrenergic Agents
Bronchial Diseases
Mometasone furoate
Anti-Asthmatic Agents
Asthma
Anti-Allergic Agents

Adrenergic Agonists
Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
Fluticasone
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Bronchial Diseases
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic Agonists
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Therapeutic Uses
Fluticasone
Dermatologic Agents

Salmeterol
Immune System Diseases
Adrenergic beta-Agonists
Mometasone furoate
Anti-Asthmatic Agents
Asthma
Anti-Allergic Agents
Pharmacologic Actions
Autonomic Agents
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on May 07, 2009